ABSTRACT
BACKGROUND:
Alcohol and other substance use disorders usually begin with substance use in
adolescence. Pediatric
primary care offices, where most
adolescents receive
health care, are a promising venue for early identification of substance use and for
brief intervention to prevent associated problems and the development of substance use disorder.
OBJECTIVE:
This study tests the effects of a
computer-facilitated
screening and brief intervention (cSBI) system (the CRAFFT [
Car, Relax, Alone, Forget,
Family/
Friends, Trouble] Interactive System [CRAFFT-IS]) on heavy episodic
drinking, riding with a driver
who is substance impaired, or driving while substance impaired among
adolescents aged 14 to 17 years presenting for a well visit at pediatric
primary care practices.
METHODS:
We are conducting a cluster
randomized controlled trial of the CRAFFT-IS versus usual care and recruiting up to 40
primary care clinicians at up to 20 pediatric
primary care practices within the American
Academy of
Pediatrics (AAP) Pediatric
Research in Office Settings network. Clinicians are randomized 11 within each practice to implement the CRAFFT-IS or usual care with a target
sample size of 1300
adolescent patients aged 14 to 17 years. At study start, intervention clinicians complete web-based modules, trainer-led live sessions, and mock sessions to establish baseline competency with intervention
counseling.
Adolescents receive mailed recruitment materials that invite
adolescents to complete an eligibility
survey. Eligible and interested
adolescents provide informed assent (parental permission requirement has been waived). Before their visit, enrolled
adolescents seeing intervention clinicians complete a
self-administered web-based CRAFFT
screening questionnaire and view brief psychoeducational content illustrating substance use-associated
health risks. During the visit, intervention clinicians access a computerized summary of the
patient's
screening results and a tailored
counseling script to deliver a
motivational interviewing-based
brief intervention. All participants complete previsit, postvisit, and 12-month
follow-up study assessments. Primary outcomes include past 90-day heavy episodic
drinking and riding with a driver
who is substance impaired at 3-, 6-, 9-, and 12-month follow-ups. Multiple
logistic regression modeling with generalized estimating equations and mixed effects modeling
will be used in outcomes analyses. Exploratory aims include examining other substance use outcomes (eg,
cannabis and
nicotine vaping), potential mediators of intervention effect (eg,
self-
efficacy not to drink), and effect moderation by baseline
risk level and sociodemographic characteristics.
RESULTS:
The AAP
Institutional Review Board approved this study. The first practice and clinicians were enrolled in August 2022; as of July 2023, a total of 6 practices (23 clinicians) had enrolled. Recruitment is expected to continue until late 2024 or early 2025.
Data collection will be completed in 2025 or 2026.
CONCLUSIONS:
Findings from this study
will inform the promotion of high-quality
screening and brief intervention efforts in pediatric
primary care with the aim of reducing alcohol-related
morbidity and
mortality during
adolescence and beyond. TRIAL REGISTRATION ClinicalTrials.gov NCT04450966; https//www.clinicaltrials.gov/study/NCT04450966. INTERNATIONAL
REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/55039.